>> All right. Welcome back, everybody. The Trump administration has cut health research funding to $2.8% billion in May.That's down 28% from April. That's according to data from the Treasury Department. Joining us right now to discuss the implications is former FDA Commissioner Scott Gottlieb.He's 2828. It's 2.8%, not 28. He's a board member with Pfizer and Illumina.Also a CNBC contributor. Doctor Gottlieb, thanks for being here today. First of all, describe what happened.Why was the funding cut and where w ...

Core Insights - Sarepta Therapeutics experienced a significant stock decline of 42% following the announcement of a second patient death linked to its gene therapy, Elevidys, leading to the suspension of its use in non-ambulatory patients for safety reviews [2][3] - Roche's reassessment of the safety profile prompted the immediate cessation of commercial distribution and a pause in ongoing clinical trials until risk mitigation measures are established [3] - Elevidys, which accounted for 43% of Sarepta's total revenues last year, was projected to achieve peak sales exceeding $3 billion, but these expectations are now under threat due to the restricted patient population [5] Financial Overview - Sarepta's financial situation was already precarious, with an operating cash flow margin of negative 25% and a net income margin of negative 11%, despite average revenue growth exceeding 40% over the past three years [6] - The company carries $1.3 billion in debt against a market capitalization of $2.06 billion, resulting in a debt-to-equity ratio of 63% [6] - The stock has seen extreme volatility, dropping from a 52-week high of approximately $172 to around $20, highlighting the risks associated with reliance on a limited number of drug revenues [7] Investment Considerations - The recent safety concerns surrounding Elevidys, combined with the company's heavy reliance on a single revenue source and significant cash burn, create a highly speculative investment environment [8] - While Sarepta's low valuations may attract contrarian investors, the investment carries substantial risks, making it suitable only for those with a high risk tolerance [8] - Investors may consider diversified investment strategies, such as the Trefis High Quality Portfolio, which spreads risk across multiple companies and sectors, rather than concentrating on individual stocks [9][10]

Regulatory Developments - The National Medical Products Administration (NMPA) is seeking opinions on optimizing the review and approval process for innovative drug clinical trials, proposing a 30-day fast track for applications of traditional Chinese medicine, chemical drugs, and biological products classified as Category 1 innovative drugs [1] - The application must meet specific criteria, including being a key innovative drug supported by national policies, included in special programs for children's drugs or rare diseases, or part of global synchronized research [1] Company Announcements - Shanghai Aikobio announced that its new drug application for Aizhida (a combination capsule for ADHD) has been accepted by the NMPA and is included in the priority review process [1] - WuXi Biologics announced a placement of 82.94 million existing shares at HKD 26.60 per share, representing approximately 2.04% of its total issued share capital [2] - Jichuan Pharmaceutical disclosed that after a share transfer, Cao Fei and Cao Longxiang became the joint actual controllers of the company, holding a combined 56.07% of the total share capital [3] - Wuhan Dazhong Oral Medical Co., Ltd. has received IPO approval to list on the Hong Kong Stock Exchange, operating 92 dental clinics across Hubei and Hunan provinces [4][5] Market Dynamics - Three Leaf Clover Biotech announced the termination of its exclusive agreement with Guoguang Biotechnology due to significant market changes, ceasing the distribution of a seasonal flu vaccine in mainland China [6] - Sanofi has re-entered the flu vaccine market after receiving approval for its quadrivalent flu vaccine for the 2025-2026 season, following a previous suspension due to efficacy issues [6] - Zhejiang Province's government procurement center announced the results for flu vaccine procurement, with prices as low as 6 CNY per dose, marking a new low for flu vaccine bids [6] Safety Concerns - Sarepta Therapeutics reported a second death related to its DMD gene therapy Elevidys, leading to a suspension of the drug's supply for non-ambulatory patients [7] Regulatory Actions - The State Administration for Market Regulation imposed a total fine of 362 million CNY on several pharmaceutical companies for engaging in price-fixing agreements [8]

[Music] Hello and welcome to Market Domination. I'm Julie Hyman. That's Josh Lipton. Live from our New York City headquarters, we are giving you the ultimate investing playbook to help tune out the noise and make the right moves for your money. And here's Headline Blitz, getting you up to speed 1 hour before the closing bell rings on Wall Street. First, I think what we're going to see at the meeting is we got these updated projections and we expect the Fed to go from two cuts this year to one and just ackno ...

A bit of a reversal Carol Massar from what we saw on Friday with the big sell off. And today it's a big buy the dip. I know.And I'm trying to figure out like how much has really changed. But having said that, I of just keep digging down. There's a lot of gainers in today's session.Semiconductors in particular, guys up almost 3%. So really some outperformance there today. I guess the optimism about perhaps Iran wants to talk to find some resolution to this.Got people more optimistic, Scarlett. But still, it ...

Sarepta Therapeutics shares sank to their lowest level in nine years Monday after a second patient taking its Elevidys drug died. https://t.co/9iQegiBx1G ...

Safety Concerns & Regulatory Impact - Serepta's gene therapy Elevidys linked to two patient deaths due to liver failure in 15 and 16-year-old boys with Duchenne muscular dystrophy [1][2] - FDA initially approved Elevidys for 4 and 5-year-olds who could still walk, later expanding the label to nearly all Duchenne patients, a decision that proved controversial due to limited evidence of efficacy in older patients [3] - Serepta has halted shipments of Elevidys for more advanced patients while exploring a new safety regimen [4] Financial Performance & Projections - Serepta is suspending its 2025 guidance and will update its full-year revenue outlook when it announces the second quarter results [4] - Prior analyst projections estimated Elevidys sales of $1.5 billion for the year, but these projections are now in serious doubt [4][5] Market Reaction & Stock Performance - Serepta's stock (SPTO) is down approximately 48% today and about 85% over the last year [5] - Safety concerns may cause eligible patients to reconsider treatment decisions [5]

Core Insights - Sarepta Therapeutics' shares fell 42% in pre-market trading following the report of a second patient death linked to its gene therapy Elevidys for Duchenne muscular dystrophy (DMD) [1] - The second fatality was due to acute liver failure, mirroring the cause of the first death reported three months prior, both involving non-ambulatory DMD patients [1][2] Company Developments - In response to the recent fatalities, Sarepta has suspended Elevidys dosing for non-ambulatory patients in commercial settings and is considering an enhanced immunosuppression regimen to improve safety [2] - The company has also paused dosing in the late-stage ENVISION study, which is crucial for regulatory approval of Elevidys outside the United States [2][3] - Despite these setbacks, Sarepta maintains that Elevidys' benefit-risk profile remains positive for ambulatory patients, and the company has communicated these developments to the FDA and other global health authorities [3] Financial Impact - The timing of the second death is particularly detrimental as Sarepta's shares have already decreased by 70% year-to-date, compared to a 1% decline in the industry [4][5] - Elevidys is a significant revenue source for Sarepta, accounting for over half of the company's revenue in Q1 2025, with sales reaching approximately $821 million in 2024, up from $200 million the previous year [7][9] - Following the first fatality, the European Medicines Agency (EMA) placed a clinical hold on Elevidys-related studies, impacting the therapy's launch plans in Europe and forcing Sarepta to lower its full-year 2025 revenue guidance from $2.9-$3.1 billion to $2.3-$2.6 billion [8][9] Product Overview - Elevidys is the first and only one-time gene therapy for DMD approved in the United States, currently authorized for individuals aged four years and older, regardless of ambulation status [10] - The therapy has received full approval for ambulatory DMD patients but only accelerated approval for non-ambulatory patients, with the ENVISION study serving as the confirmatory trial for full approval [10] - Sarepta developed Elevidys in partnership with Roche, which holds exclusive rights to market the therapy in non-U.S. markets [11]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Viewpoint - The article provides insights into the investment landscape, emphasizing the importance of thorough research and independent verification of information before making investment decisions [2][3]. Group 1: Company Insights - The article does not mention specific companies or their financial performance, focusing instead on general investment advice and the need for due diligence [2][3]. Group 2: Industry Analysis - The content highlights the inherent volatility and risks associated with stock investments, suggesting that past performance is not indicative of future results [3]. - It underscores the role of analysts in providing probabilistic assessments rather than absolute certainties in investment recommendations [2].